The Bochum Optimizing Clopidogrel-Aspirin Therapy and MORTality Study (BOCLA-Mort)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horst Neubauer, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01796691
First received: February 17, 2013
Last updated: February 24, 2013
Last verified: February 2013
  Purpose

Comparing standard treatment versus optimized antiplatelet therapy and outcomes measures.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Optimized Antiplatelet Therapy With Aspirin and Clopidogrel Improves Mortality Compared to Standard Treatment.

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Adverse cardiac events (MACE: mortality,rehospitalisation,myocardial infarction) [ Time Frame: Follow up for up to 12 months (retrospective analysis) ] [ Designated as safety issue: No ]
    MACE-rate


Enrollment: 600
Study Start Date: January 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Standard therapy
Antiplatelet therapy following coronary stenting without platelet function testing
Optimized antiplatelet therapy

Platelet function testing and according to a test and treat strategy improve the antiplatelet therapy in low-responder.

Treatment adjustments were done as published before - see BOCLA-Plan manuscript. (Reference: Tailored antiplatelet therapy can overcome clopidogrel and aspirin resistance--the BOchum CLopidogrel and Aspirin Plan (BOCLA-Plan) to improve antiplatelet therapy. BMC Med. 2011 Jan 12;9:3.)


Detailed Description:

The study is aimed to evaluate if optimized antiplatelet treatment using a test and treat algorithm (with whole blood aggregometry) is able to improve clinical outcome of patients compared to standard treatment without platelet function testing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients following coronary stenting if informed consent was obtained

Criteria

Inclusion Criteria:

  • coronary stent implantation

Exclusion Criteria:

  • no consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796691

Locations
Germany
Cardiovascular Center, Ruhr-University Bochum
Bochum, NRW, Germany, D-44791
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Horst Neubauer, MD Ruhr-University Bochum, Cardiovascular Center
  More Information

Publications:
Responsible Party: Horst Neubauer, PHD, MD, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01796691     History of Changes
Other Study ID Numbers: BOCLAplan02, [Ruhr-University Bochum]
Study First Received: February 17, 2013
Last Updated: February 24, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
Clopidogrel
aspirin
low response
platelet aggregation
Acute Coronary Syndrome
Coronary Stent Implantation

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Aspirin
Clopidogrel
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents

ClinicalTrials.gov processed this record on October 22, 2014